NephroGenex, Inc. Announces Presentation at the American Society of Nephrology’s Kidney Week 2014
NephroGenex, Inc. (Nasdaq:NRX), a pharmaceutical company focused on the development of therapeutics to treat kidney disease, announced the presentation of the novel design of its Phase 3 Pyridorin PIONEER clinical program at the American Society of Nephrology (ASN) Kidney Week meeting held here November 11-16, 2014.
“Our poster presentation at the ASN highlights the key outcomes from our Phase 2 studies with Pyridorin in diabetic nephropathy, and how they informed the design of our pivotal Phase 3 study launched earlier this year,” said Pierre Legault, Chief Executive Officer of NephroGenex. “The Phase 3 protocol, agreed to by the FDA under a Special Protocol Assessment, includes a new renal endpoint that reduces patient follow-up time and cost by approximately 50% compared to previous studies in this disease. The FDA’s willingness to accept new renal endpoints, with lower levels of renal decline, is an important and welcomed change in the effort to develop improved therapies for chronic kidney diseases. We’re pleased to be one of the first companies to incorporate this new endpoint into a registration study.”
NephroGenex poster highlights protocol incorporating new renal endpoint
In its poster presentation, titled “Rationale and Study Design of Pyridoxamine dihydrochloride (Pyridorin) in Type 2 Diabetic Nephropathy (PIONEER-CSG-17),” posted at the meeting (INFO22) and published online (PUB181), the authors outline lessons learned from the Pyridorin Phase 2 program that were incorporated into the design of the Phase 3 study. The Phase 2 trial showed a greater than 50% treatment effect in patients with mild to moderate disease and in patients with advanced disease who had previously established a stable regimen of standard of care. Those findings informed the criteria for patient inclusion and the requirement for establishing a long-term stable regimen of standard of care medications prior to randomization to assure a stable serum creatinine (SCr) baseline. The primary endpoint for the study is a time-to-event analysis of the composite of an increase of SCr of >=50% from baseline or End Stage Renal Disease (ESRD). The poster was authored by members of the Collaborative Study Group (CSG) and NephroGenex.
New renal endpoints measuring lower renal decline supported by FDA-National Kidney Foundation scientific workshop
The primary endpoint of an increase of SCr of >=50% is a new renal endpoint that NephroGenex proposed and the FDA agreed to under a Special Protocol Assessment. The historical endpoint for chronic kidney disease (CKD) clinical trials has been a reduction by one-half of the estimated glomerular filtration rate (eGFR), assessed as a doubling of serum creatinine level (increased SCr of >=100%). This new endpoint (increased SCr of >=50%) will reduce patient follow-up time by approximately 50% and will also require fewer patients in a trial in order to accrue the necessary number of events. The use of this new endpoint was supported by the conclusions of a joint FDA-National Kidney Foundation scientific workshop that levels substantially lower than an equivalent SCr increase of >=100% can be used to predict time to ESRD. The findings of the December 2012 workshop, which involved the evaluation of CKD clinical trial datasets with over 1.5 million participants and 12,000 ESRD events, were published online on October 15, 2014 in the American Journal of Kidney Disease.
A separate poster being presented at the ASN meeting also supports the use of lower degrees of renal decline as viable predictors of ESRD. “Intermediate Creatinine-based Endpoints Reliably Predict Outcome: Results from IDNT and RENAAL” (FR-PO900) by Collaborative Study Group authors, will be presented on Friday, November 14. The study’s abstract showed that a confirmed >=35% increase in serum creatinine levels over 12 months, or >=50% over 18 months, are strong predictors of end stage renal disease.
The NephroGenex Phase 3 PIONEER study, launched in mid-June 2014, is a randomized, double-blind, placebo-controlled, international, multicenter trial that will involve approximately 600 patients with diabetic nephropathy. NephroGenex has partnered with the CSG for the design and conduct of this pivotal trial, as well as its previous Phase 2b study. The CSG is an academic research organization focused on kidney disease with over 300 affiliated clinics worldwide.
About Diabetic Nephropathy
Diabetic nephropathy is a chronic, degenerative disease of the kidney caused by diabetes. There are approximately 6 million patients with diabetic nephropathy in the United States (approximately 33% of diagnosed diabetics) and this population is expected to grow. Patients suffering from diabetic nephropathy progress to End Stage Renal Failure or death. There are currently no adequate treatments for this disease.
About NephroGenex, Inc.
NephroGenex (NASDAQ:NRX) is a clinical-stage pharmaceutical company focused on developing therapeutics to treat kidney diseases caused by pathogenic oxidative chemistries. Since our inception, we have collaborated with the leading scientific experts in pathogenic oxidative chemistries to build a strong portfolio of intellectual property and novel acting drug candidates. Our clinical program has been done in collaboration with world leading clinical investigators in kidney disease. Our product pipeline includes an oral formulation of Pyridorin, which is being developed as a chronic, therapeutic agent to slow the progression of diabetic nephropathy, as well as an intravenous formulation of Pyridorin to treat specific types of acute kidney injury.
Cautionary Note on Forward-Looking Statements
This press release contains certain statements that are, or may be deemed “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will,” or words of similar meaning and include, but are not limited to, statements regarding the outlook for our future business and financial performance. Forward-looking statements are based on our current expectations and assumptions, which are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Actual outcomes and results may differ materially from those in the forward-looking statements due to global political, economic, business, competitive, market, regulatory and other factors and risks, including the items identified under “Part I-Item 1A-Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2013, filed with the Securities and Exchange Commission (“SEC”) on March 31, 2014, as well as in other filings that we may make with the SEC in the future. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we do not undertake and specifically disclaim any obligation to update any forward-looking statements.
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